Brentuximab Vedotin (bren-TUX-i-mab ve-DOE-tin)

Treats cancer, including Hodgkin lymphoma, systemic anaplastic large cell lymphoma, peripheral T-cell lymphoma, and primary cutaneous anaplastic large cell lymphoma.

Brand Name(s):

Adcetris

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. This medicine must be given slowly, so the needle will have to stay in place for at least 30 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• You may also receive other medicines (including fever medicine, allergy medicine, steroids, G-CSF) to help prevent possible allergic reactions to the injection.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not receive this medicine together with bleomycin.
• Some medicines can affect how brentuximab works. Tell your doctor if you are using ketoconazole or rifampin.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control during treatment with this medicine and for at least 2 months after your last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 4 months after the last dose.
• Do not breastfeed during treatment with this medicine.
• Tell your doctor if you have kidney disease, liver disease, diabetes, lung or breathing problems, or stomach or bowel problems.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may cause the following problems:
  • Peripheral neuropathy (nerve problem)
  • Infusion reaction
  • Increased risk for serious infections
  • Tumor lysis syndrome (electrolyte and metabolic problem that can be life-threatening)
  • Liver problems
  • Progressive multifocal leukoencephalopathy (brain infection that can be life-threatening)
  • New or worsening lung problems
  • Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis
  • Stomach or bowel problems, including bleeding, blockage, perforation, or ulcers
  • High blood sugar
• Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Confusion, changes in mood or behavior, problems with vision, speech, memory, or walking
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Difficult or painful urination, bloody or cloudy urine
• Fever of 100.5 degrees F or higher, chills, cough, sore throat, body aches
• Increased hunger or thirst, dry mouth, sweating
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Severe stomach pain, bloody or black stools, vomiting of material that looks like coffee grounds
• Trouble breathing, coughing up blood, headache
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, mild stomach pain
• Decreased weight
• Tiredness
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088